Catalog Number

7812400

Brand Name

Groshong NXT ClearVue

Version/Model Number

7812400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

fee99b89-fa6c-48a7-8545-aec720d912ce

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

June 07, 2016

Package DI Number

10801741075268

Quantity per Package

10

Contains DI Package

00801741075261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA